Side Effects of Pulmonary Hypertension Medications
The study seeks to analyze the patient reported effects of pulmonary hypertension medications and compare these with the side effects described on the package inserts. Side effects for these PH medications have been described in the adult population, but have never been described in the pediatric population. This information can better improve patient care and be used to characterize the side effects resultant from these medications.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications|
- Patients Experience Side Effects [ Time Frame: Open ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Pediatric patients with pulmonary hypertension
As part of standard of care, patients are routinely asked about any symptoms they might be experiencing. This study seeks to quantify these symptoms for research purposes. Participants will be identified through those who attend the pediatric pulmonary hypertension clinic at LPCH. Only children who are currently on one of seven PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris) will be approached. Patients who consent to be in the study will answer a brief series of questions pertaining to the presence and duration of their symptoms. These will be correlated to a list of side effects taken from Lexicomp (a medication database).
|Contact: Jeffrey Feinstein, MD, MPH||650 723 email@example.com|
|United States, California|
|Lucile Packard Children's Hospital at Stanford||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Jeffrey Feinstein, MD, MPH 650-723-7913 firstname.lastname@example.org|
|Principal Investigator: Jeffrey Feinstein, MD, MPH|